Table 1

Demographics and baseline characteristics

Placebo
(n=282)
Tanezumab 2.5 mg
(n=283)
Tanezumab 5 mg
(n=284)
Sex, n (%)Male86 (30.5%)85 (30.0%)91 (32.0%)
Female196 (69.5%)198 (70.0%)193 (68.0%)
Age, yearsMean (SD)64.2 (9.6)65.2 (8.4)65.2 (10.2)
Range26–8741–8832–89
Race, n (%)White247 (87.6%)245 (86.6%)248 (87.3%)
Black or African-American000
Asian34 (12.1%)38 (13.4%)34 (12.0%)
Other1 (0.4%)02 (0.7%)
Body mass index, kg/m2 Mean (SD)30.4 (4.8)29.9 (4.8)30.3 (4.6)
Range20–3920–3917–39
Time since index joint OA diagnosis, yearsMean7.46.06.7
Range0–37.90–30.60–37.7
Index joint, n (%)Hip47 (16.7%)49 (17.3%)48 (16.9%)
Knee235 (83.3%)234 (82.7%)236 (83.1%)
Kellgren-Lawrence grade of index joint, n (%)*002 (0.7)†0
1000
259 (20.9%)49 (17.3%)58 (20.4%)
3123 (43.6%)131 (46.3%)121 (42.6%)
4100 (35.5%)101 (35.7%)105 (37.0%)
WOMAC Pain subscale scoreMean (SD)6.59 (0.94)6.70 (0.94)6.60 (0.89)
Range4.4–9.42.8–10.04.6–9.6
WOMAC Physical Function subscale scoreMean (SD)6.67 (0.87)6.77 (0.87)6.76 (0.88)
Range5.1–9.44.9–9.84.6–9.4
PGA-OA score, n (%)Very good001 (0.4%)
Good001 (0.4%)
Fair145 (51.6%)132 (46.8%)136 (47.9%)
Poor117 (41.6%)129 (45.7%)129 (45.4%)
Very poor19 (6.8%)21 (7.4%)17 (6.0%)
  • *Kellgren-Lawrence grade for classifying OA severity, ranging from 0 (no OA) to 4 (severe OA).

  • †In the tanezumab 2.5 mg group, two patients with OA grade 0 were included as a result of protocol deviations.

  • OA, osteoarthritis; PGA-OA, Patient’s Global Assessment of osteoarthritis; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.